Clinical trials: Medical Devices
Thromboembolic Events
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States…
- Trial name
- NCT02052544
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 123 people
- Sponsor
- dsm-firmenich Switzerland AG
Self Care
Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic Youth
The purpose of this clinical investigation is to provide pilot clinical data to direct pivotal study development for the pediatric indication of the Senseonics Continuous Glucose Monitoring System (CGM) measurements when compared…
- Trial name
- FNH (NCT03815552)
- Testing
- Eversense Continuous Glucose Monitoring
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Kinderkrankenhaus auf der Bult
Diagnostic and/or Interventional Radiology Procedures
Angio-Seal Interventional Radiology (IR) Registry
The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient…
- Trial name
- NCT01222104
- Where
- 10 sites in United States
- Volunteers
- 634 people
- Sponsor
- Abbott Medical Devices
COVID-19, Asymptomatic COVID-19
A Clinical Evaluation of Proof Diagnostics Test System Including the Proof Diagnostics Reader and COVID-19 Test
To determine the accuracy of Proof Diagnostics COVID-19 Test in the intended, symptomatic and suspected/at-risk asymptomatic population and point-of-care use as compared to a standard molecular comparator, Quidel Lyra SARS-CoV-2…
- Trial name
- NCT05331976
- Testing
- Proof Lab Test System
- Where
- 3 sites in United States
- Volunteers
- 276 people
- Sponsor
- Proof Diagnostics
Self-Help Devices, Eye-Gaze Technology
Applying Eye-Gaze Assistive Technology for Children and Youth With Complex Needs
The purpose of this research is to investigate the impacts of applying eye-gaze assistive technology (AT) in children and youth with severe disabilities and complex needs in Taiwan, where eye-gaze AT has not been researched for…
- Conditions
- Self-Help Devices, Eye-Gaze Technology, Severe Physical Disabilities, Communication Disorders
- Trial name
- NCT04377893
- Testing
- Eye gaze AT intervention
- Where
- Sweden
- Volunteers
- 5 people
- Sponsor
- Yu-Hsin Hsieh
Chronic Sinusitis
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.
- Trial name
- INTACT (NCT00939471)
- Testing
- Relieva™ Balloon Sinuplasty™ System
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Angiopathies, Intermittent Claudication
Trial Comparing Different Medical Devices for Infragenual Dilatation
This study is a comparison of different medical devices for infragenual dilatation.
- Trial name
- NCT00134277
- Testing
- Infragenual dilatation, Infragenual dilatation with stenting, Infragenual dilatation with cutting balloon
- Where
- Belgium
- Volunteers
- 35 people
- Sponsor
- University Hospital, Ghent
Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac…
- Trial name
- NCT02091011
- Where
- 80 sites in United States, Canada and 6 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Cerumen Impaction, Earwax Impaction
Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax.
The ear canal - or external auditory meatus - is lined with skin that contains ceruminous glands. Cerumen - or earwax - is a combination of epithelial cells, dust, foreign bodies, as well as the secretions of the sebaceous glands…
- Conditions
- Cerumen Impaction, Earwax Impaction, Earwax Plug
- Trial name
- EAR (NCT07834593)
- Testing
- Unidose cerumenolytic solution, Spray cerumenolytic solution
- Where
- 3 sites in France
- Volunteers
- 80 people
- Sponsor
- Laboratoires Gilbert
Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle
BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan
The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) compared to marrow stimulation in the treatment of chondral and osteochondral lesions located on the medial…
- Conditions
- Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle, Chondral or Osteochondral Lesion of Trochlea
- Trial name
- NCT01477008
- Testing
- BiPhasic Cartilage Repair Implant, Marrow Stimulation
- Where
- 11 sites in Taiwan
- Volunteers
- 92 people
- Sponsor
- BioGend Therapeutics Co.Ltd
Hemoglobins
Non-invasive Measurement of Hemoglobin in Infants and Neonates
Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective congenital heart surgery, weighing between 3kg and 20 kg.
- Trial name
- NCT02655107
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University Hospital Schleswig-Holstein
Ultrasound
Learning Outcomes With Point-of-Care Ultrasound
Point-of care-ultrasonography has the potential to transform healthcare delivery through its diagnostic and therapeutic utility.
- Trial name
- NCT04021693
- Testing
- Handheld Ultrasound Devices
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Stanford University
Phimosis, Foreskin; Tightness
Safety and Efficacy of the Sterile Single-use Circular Stapling Device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
Evaluation of the safety and efficacy of the sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) in comparison with circumcision in adults patients with…
- Conditions
- Phimosis, Foreskin; Tightness, Redundant Prepuce
- Trial name
- CiCi-2021 (NCT04902898)
- Testing
- Circumcision in adults using sterile single-use circular stapling device, Circumcision in adults
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- University of Thessaly
Cerebral Palsy (CP)
Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy
The goal of this clinical trial is to evaluate the safety and effectiveness of the Bambini Teens exoskeleton as a gait training tool in children aged 5 to 14 years diagnosed with cerebral palsy (CP).
- Trial name
- NCT07146932
- Testing
- Pediatric Lower Limb Exoskeleton (Bambini Teens)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- COSMO ROBOTICS CO., Ltd
Peripheral Intravenous Catheter Stabilization
A 7 Day Adhesive Device Wear Study to Evaluate BD StatLock™ Devices
This study is a prospective healthy human volunteer wear study to evaluate the safety and performance of the StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device Accessory (Foam Strip) and to meet the…
- Trial name
- NCT04845906
- Testing
- StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip)
- Where
- 2 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Becton, Dickinson and Company
Type 1 Diabetes
Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in Kenya.
Diabetes mellitus (diabetes) is a chronic condition that represents a major public health and clinical concern. Self-monitoring of blood glucose (SMBG) is a critical part of the care of individuals with diabetes.
- Trial name
- ACCEDE (NCT05944731)
- Testing
- Continuous glucose monitor
- Where
- Kenya
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Intubation
Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients
The purpose of this study is to compare the effectiveness of two novel videolaryngoscope systems, the Glidescope and the Truview PCD against standard direct laryngoscopy (DL) in pediatric patients.
- Trial name
- NCT01023568
- Testing
- Macintosh blade, Glidescope, Truview PCD
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- The Cleveland Clinic
Hepatolenticular Degeneration; Wilson
Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from Wilson's Disease. The main questions it aims to answer are: Does the device work as expected by removing the excess of…
- Trial name
- MEXWILS (NCT05917327)
- Testing
- Low-volume continuous veno-venous haemodialysis
- Where
- 4 sites in France, Spain
- Volunteers
- 1 people
- Sponsor
- Mexbrain
Cystic Fibrosis, Healthy
Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children
This study compares the lung clearance index (LCI) in cystic fibrosis and healthy children obtained with two different multiple breath nitrogen washout (MBWN2) devices.
- Trial name
- NCT02378454
- Testing
- Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"
- Where
- Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Heart Failure, Cardiogenic Shock
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to: 1.
- Conditions
- Heart Failure, Cardiogenic Shock, Congenital Heart Disease, Cardiomyopathies
- Trial name
- TROLLEY (NCT06080074)
- Testing
- Cardiohelp device (VA-ECMO), Heparin, Bivalirudin
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Stanford University